Flaws in Epic sepsis algorithm show need for stronger oversight of AI

(MOLLY FERGUSON FOR STAT)

Epic, the dominant purveyor of health-records software, markets its sepsis-detection tool as a life-saving technology. That invites comparisons to a highly effective drug, but unlike a drug, it underwent no FDA review or third-party testing before its initial release. No independent systems monitor its use across hospitals or report problems. And its benefits and side effects were not measured in a randomized trial before it was plugged in at facilities around the country.

As STAT’s Casey Ross has reported in a series of investigations, Epic’s AI tool to predict sepsis, a deadly complication of infection, was prone to missing cases and sending false alarms. Epic has remade it, changing the data variables it uses, its definition of sepsis onset, and its guidance for tuning the algorithm to local patients. It’s a case study in the urgent need for stepped-up oversight of AI products. Read more about how it unfolded.

One more way women and men differ in heart health

Thanks to 70 volunteers who laid on their backs in a pressure-controlled chamber, riding a suspended stationary bike while an ultrasound imager pointed at their pumping heart, we have evidence of one more way in which women are not just smaller men. A recent study in Science Translational Medicine reports that women’s lean body mass, made up mostly of skeletal muscle, correlates with a better-functioning heart, while men’s does not.

Women with more muscle in their arms and legs also tended to have hearts with larger inside diameters, allowing their hearts to pump more oxygenated blood. And the walls of their hearts did not appear to be thickening, a good sign for heart failure prevention. There was no correlation between men’s lean body mass and these heart characteristics, even though it’s well known that men have significantly more lean body mass than women. STAT’s Jayne Williamson-Lee has more.

Inside the sudden exit of BIO’s leader

STAT published an exclusive from Rachel Cohrs about Michelle McMurry-Heath’s departure from BIO, after the last edition of Morning Rounds hit your inbox, so I want to draw your attention to it now. McMurry-Heath was named chief executive of the world’s largest biotech trade organization two years ago. She was hailed by her predecessor as a “great leader,” so her abrupt exit earlier this month shocked the industry.

Even before McMurry-Heath took over, there had been simmering tensions among the trade association’s corporate members but she had her own clashes with the board. And at least 100 employees have departed BIO since McMurry-Heath took over in June 2020, according to a STAT review, in an organization that in 2020 employed fewer than 200. McMurry-Heath did not respond to several requests for comment for this story, which includes details from inside sources on her sudden exit. Read more.

Closer look: A son calls for ICUs to open their doors to families

(Andrew Selsky/AP)

One of the cruelest side effects of the Covid pandemic has been hospitals’ separating families from their loved ones as they end their days alone in ICUs. Even as people now go about their daily lives without masks or other precautions, many ICUs still restrict visitors. It’s one of the most inhumane of the flawed Covid-19 policies, Neel Vahil, a first-year resident in internal medicine, writes in a STAT First Opinion about losing his father and the chance to be with him.

“If my family had the opportunity to see the severity of my Dad’s clinical condition days earlier, we likely would have transitioned him to comfort care that would have spared him needless and often painful interventions toward the end of his life,” he writes. “It’s time to push [hospital ICUs] to once again open their doors and make family-centered care a priority.” Read more.

The cadence of Covid boosters keeps this FDA official up at night

Knowing that SARS-CoV-2 viruses mutate rapidly means understanding that vaccines and boosters can last only so long, so it’s conceivable the booster shot people are getting now may not be the last some will need for the coming year. That concerns Peter Marks, who leads the FDA’s vaccines operation. “I would be lying to you if [I said] it doesn’t keep me up at night worrying that there is a certain chance that we may have to deploy another booster — at least for a portion of the population, perhaps older individuals — before next September, October,” Marks told STAT’s Helen Branswell.

While current mRNA vaccines perform remarkably well against severe disease, hospitalization, and death, protection against contracting Covid is short-lived. The long-term answer would be to redesign the vaccines. Read more about what’s involved.

Study finds an association between vaccine reactions and antibody levels

As someone who’s been laid low by each Covid vaccine dose I’ve gotten, I have wondered if my common reaction can say anything about protection. That’s why this study in JAMA Network Open piqued my interest. So far the research has been mixed, but among more than 900 participants in the Framingham Heart Study with an average age of 65, nearly half reported systemic symptoms such as fever, muscle pain, headache, vomiting, and fatigue.

When the participants’ antibody levels were measured, those who had systemic reactions to their vaccine doses had a greater antibody response compared to those who had only local symptoms, like a sore arm, or no symptoms. Older age, being female, and getting the Moderna vaccine were associated with a greater antibody response, but race, BMI, or underlying conditions were not, “highlighting unexplained interpersonal variability.” Caveats: Symptoms were self-reported; most participants were white.

What we're reading

Merck locates frozen batch of undisclosed Ebola vaccine, will donate for testing in Uganda’s outbreak, Science
Three New Yorkers ordered cocaine from the same delivery service. All died from fentanyl, Wall Street Journal
Why gay men and other groups are banned from donating sperm, Washington Post
This summer’s Covid surge was bad for hospital profits, STAT
Growing scrutiny of a quality standard that may influence end-of-life decisions for heart surgery patients, Boston Globe
Opinion: Medical professionals: Make your plan to vote now. Then vote! STAT